Disposable, presterilized, self-locating and piercing evacuator with ejector tube

ABSTRACT

The present invention is a simple, inexpensive and consequently disposable, self-piercing and locating combination evacuator and ejector tube which can be encased in a sheath, presterilized ready for use, and includes a spearhead-type body with spaced cutting edges diverging from a pointed top rearwardly, and with a shoulder or flange spaced beyond the rear limits of said cutting edges, with a reduced portion therebetween so that when the device is used to pierce a membrance such as an eardrum, skin or other body portion, such skin or membrane will be disposed in such reduced portion with the handle or ejector tube removed, and the device left in the incision until healing has occurred, whereupon it can be readily removed. Thus the evacuator is of a construction to have superior holding qualities, to provide minimum interference with nature&#39;&#39;s healing, and is of a composition readily recognizable as suitable for implantation in the human body.

United States Patent Capote Feb. 29, 1972 [54] DISPOSABLE, PRESTERILKZED, SELF- LOCATING AND PIERCING EVACUATOR WITH EJECTOR TUBE 21 Appl. No.: 883,718

[56] References Cited UNITED STATES PATENTS 3,358,684 12/1967 Marshall ..l28/2l4.4

3.5 30,860 9/1970 Majoros.... 1,465,793 8/ l 923 Schilling ..222/90 OTHER PUBLICATIONS Sheehy. Collar Button Tube for Chronic Serous Otitis, ln Trans. Amer. Acad. Ophth. and Otol. V0. 68, 1964, pp. 888- 889.

Morgan, Myringotomy Tube lnserter, ln. Arch. Otolaryng. Vol. 84. Sept. 1966. p. 131.

Christopher, Textbook of Surgery, 8th Ed. 1961. pp. 241- 242.

Primary ExaminerChanning L. Pace Attorney-A. Yates Dowell and A. Yates Dowell, Jr.

[57] ABSTRACT The present invention is a simple, inexpensive and consequently disposable, self-piercing and locating combination evacuator and ejector tube which can be encased in a sheath, presterilized ready for use, and includes a spearhead-type body with spaced cutting edges diverging from a pointed top rearwardly, and with a shoulder or flange spaced beyond the rear limits of said cutting edges, with a reduced portion therebetween so that when the device is used to pierce a membrance such as an eardrum, skin or other body portion, such skin or membrane will be disposed in such reduced portion with the handle or ejector tube removed, and the device left in the incision until healing has occurred, whereupon it can be readily removed. Thus the evacuator is of a construction to have superior holding qualities, to provide minimum interference with natures healing, and is of a composition readily recognizable as suitable for implantation in the human body.

3 Claims, 5 Drawing Figures PAIENTEUFEB29I912 3,645,268

INVENTOR NEYS DISPOSABLE, PRESTERILIZED, SELF-LOCATING AND PIERCING EVACUATOR WITH EJECTOR TUBE BACKGROUND OF THE INVENTION 1 Field of the Invention The invention is in the field of surgical instruments particularly suitable for use in the treatment of the human body in the area of the ears and other membranes in the body where evacuation or the like is desired.

2. Description of the Prior Art Various types of surgical instruments have been provided including those for puncturing the tympanic membrane which closes externally the cavity of the middle ear, and myringotomy tube inserters for inserting relatively short plastic tube lengths to maintain openings in such tympanic membrane. The use of these prior art devices has required too much time and the application of the same has depended largely upon the skill of the user with excessive injury as well as a psychological frightening effect on the patient.

SUMMARY OF THE INVENTION AND OBJECTS This invention is a simple, presterilized, small, disposable body which can be easily and quickly applied by a physician, with negligible opportunity for error and minimum injury to and frightening of a patient, to allow discharge from an inner area to the exterior through a membrane such as the eardrum or through the skin or other portion of the body. Such device is self-orienting and overinsertion-preventing and somewhat similar to a spearhead with multiple, spaced, inclined cutting edges for facilitating insertion through such membrane, beyond the rear limits of which cutting edges is a reduced portion with an annular flange for limiting the penetration through the pierced membrane, skin, or other body part, somewhat the way an earring is fitted to the ear, and requiring minimum skill in applying, and the device also ofiers minimum interference to nature's healing after drainage has been accomplished and is of a character readily and easily removable after healing has occurred. A holder for the tool and the tool itself are of plastic or other suitable material acknowledged as suitable for implantation within the human body.

It is an object of the invention to provide a simple, inexpensive, and consequently disposable, self-piercing and locating combination evacuator with a disposable ejector tube and which can be presterilized and the application of which can be accurately and effectively accomplished with the requirement of minimum skill with minimum injury to, and frightening of, a patient.

Another object of the invention is to provide an otology drainage implant for the middle ear or other area having a collection of fluid in the tissues of the body, and which implant is a self-piercing evacuator or drainage member with a disposable, plastic ejector-locator of a material recognized as suitable for human implantations such as Teflon, polyethylene, Delrin, Nylon, stainless steel, Titanium, cobalt chrome alloys, or other recognized substances.

A further object of the invention is to provide a self-piercing, self-locating evacuator with a plastic cover maintaining the device sterilized until used and of a character to prevent overinsertion as well as to offer minimum interference with the healing process.

BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a perspective of the self-piercing, self-locating evacuator of the present invention;

FIG. 2, a front elevation; and FIGS. 3, 4 and 5, views illustrating the succemive steps in the application of the device to the tympanic membrane or eardrum of the human body.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to the drawing, the evacuator of the present in vention is generally in the form of a hollow elongated body having a conical penetrating point 10' with multiple piercing or cutting edges 11, three of which have been found satisfactory for an incision of the tympanic membrane 12, or an operation referred to in the medical profession as myringotomy. The evacuator or drainage member also may be used to remove accumulated liquid from beneath the skin of other parts of the body.

At the rear extremities of the conical point 10' of the evacuator, the body is provided with a reduced portion 15 with an annular flange 16 providing an area in which the pierced membrane 12 is adapted to be received. The flange 16 serves to prevent excessive penetration or overinsertion and also serves to be gripped for removal of the evacuator after drainage and healing of the membrane which has been pierced.

The body 10 has a central axial bore 17 extending therethrough and terminating in openings 17 located in the conical point 10' between the cutting edges 11. The bore 17 provides a drain passageway so that liquids can enter through the openings 17' and pass through the bore 17 to the exterior of the tympanic membrane 12.

With reference to FIGS. 1, 3 and 4, an applicator instrument is provided for inserting the evacuator into the membrane 12 or other tissue. Such applicator instrument includes a holding member or rod 19 having a reduced portion 18 at one end defining a shoulder 20. The reduced end portion 18 is of a size to be frictionally received within the bore 17 of the evacuator with the flange 16 in engagement with the shoulder 20. The rod 19 is axially slidably mounted within a sleeve 21, one edge of which defines a shoulder 22 against which the flange l6 normally abuts.

The opposite end of the rod 19 extends outwardly beyond the sleeve 21 and is connected to such sleeve by a spring yoke 23, as illustrated in FIG. 3. The spring yoke 23 normally maintains the flange 16 of the evacuator against the shoulder 22 of the sleeve. When the evacuator has been inserted, the rod 19 is moved axially rearwardly to separate the reduced end portion 18 from the bore 17 of the evacuator while the shoulder 22 prevents rearward movement of the evacuator.

In order to facilitate the introduction of the holder with the evacuator on the end thereof, a funnel-type guide member 24 may be provided, such guide member having a flared outer end 25 and a reduced or relatively small end 26 which is adapted to extend into the ear channel 27 leading to the tympanic membrane which closes externally the cavity over the middle car.

In order to have the evacuator ready for use, it and its holder preferably are provided with a plastic cover which may be readily removed prior to the otology implant for drainage of the middle ear or for implant in another area where there is a localized collection of fluid, such as pus in the tissues of the body.

In the use of the device the sleeve 21 is gripped with the thumb and forefinger and the device is inserted through a funnel-type guide when it is to be used in the area of the ear. A slight force is applied axially to the sleeve 21 to cause the evacuator to pierce the membrane until stopped by the flange 16. Thereafter, the reduced end portion 18 is retracted from the bore 17 of the evacuator and the applicator instrument is removed leaving the evacuator in position.

I claim:

1. An evacuator for insertion in living tissue to drain fluids therefrom, said evacuator comprising a hollow elongated body, stop means at one end of said body to substantially prevent overinsertion in the tissue, a tapered generally conical portion at the opposite end of said body and terminating in a penetrating point remote from said stop means, a reduced diameter portion connecting said conical portion to said stop means, and said body having an axial bore extending from the end adjacent said stop means and communicating with the surface of said conical portion through an opening on said surface to provide a passageway substantially through said body so that fluids from the tissue can flow through said passageway and drain from said body, whereby axial movement of said evacuator in the direction of the tapered portion pierces the living tissue and continued axial movement imbeds said conical portion within the tissue and said stop means resists overinsertion of the evacuator into the tissue.

2. The structure of claim 1 including a plurality of cutting edges located along said generally conical portion and extending from said penetrating point to a position adjacent to said reduced diameter portion.

3. The combination of an evacuator for insertion in living tissue to drain fluids therefrom and an instrument for inserting the evacuator into the tissue, said evacuator comprising a hollow elongated body, stop means at one end of said body, a tapered generally conical portion at the opposite end of said body and terminating in a penetrating point remote from said stop means, a reduced diameter portion located between said conical portion and said stop means, said body having an axial bore extending from the end adjacent said stop means and communicating with the surface of said conical portion through an opening on said surface to provide a passageway substantially through said body so that fluids from the tissue can flow through said passageway and drain from said body, said instrument comprising an elongated sleeve, rod means axially slidably mounted within said sleeve, said rod means having a reduced portion at one end, said reduced portion normally extending outwardly of one end of said sleeve and frictionally engaging the bore of said evacuator, the opposite end of said rod means extending outwardly from the opposite end of said sleeve, resilient means connecting the opposite end of said rod means to the opposite end of said sleeve and adapted to urge the stop means of said evacuator into engagement with said one end of said sleeve, whereby axial movement of said sleeve in one direction causes said evacuator to penetrate the tissue after which said rod means can be moved in the opposite direction to cause the reduced portion of said rod means to be withdrawn from the bore of said evacuator while said sleeve prevents axial movement of said evacuator. 

1. An evacuator for insertion in living tissue to drain fluids therefrom, said evacuator comprising a hollow elongated body, stop means at one end of said body to substantially prevent overinsertion in the tissue, a tapered generally conical portion at the opposite end of said body and terminating in a penetrating point remote from said stop means, a reduced diameter portion connecting said conical portion to said stop means, and said body having an axial bore extending from the end adjacent said stop means and communicating with the surface of said conical portion through an opening on said surface to provide a passageway substantially through said body so that fluids from the tissue can flow through said passageway and drain from said body, whereby axial movement of said evacuator in the direction of the tapered portion pierces the living tissue and continued axial movement imbeds said conical portion within the tissue and said stop means resists overinsertion of the evacuator into the tissue.
 2. The structure of claim 1 including a plurality of cutting edges located along said generally conical portion and extending from said penetrating point to a position adjacent to said reduced diameter portion.
 3. The combination of an evacuator for insertion in living tissue to drain fluids therefrom and an instrument for inserting the evacuator into the tissue, said evacuator comprising a hollow elongated body, stop means at one end of said body, a tapered generally conical portion at the opposite end of said body and terminating in a penetrating point remote from said stop means, a reduced diameter portion located between said conical portion and said stop means, said body having an axial bore extending from the end adjacent said stop means and communicating with the surface of said conical portion through an opening on said surface to provide a passageway substantially through said body so that fluids from the tissue can flow through said passageway and drain from said body, said instrument comprising an elongated sleeve, rod means axially slidably mounted within said sleeve, said rod means having a reduced portion at one end, said reduced portion normally extending outwardly of one end of said sleeve and frictionally engaging the bore of said evacuator, the opposite end of said rod means extending outwardly from the opposite end of said sleeve, resilient means connecting the opposite end of said rod means to the opposite end of said sleeve and adapted to urge the stop means of said evacuator into engagement with said one end of said sleeve, whereby axial movement of said sleeve in one direction causes said evacuator to penetrate the tissue after which said rod means can be moved in the opposite direction to cause the reduced portion of said rod means to be withdrawn from the bore of said evacuator while said sleeve prevents axial movement of said evacuator. 